HiRes 90K™ Replacement Magnet

GUDID 00840094456198

1

Advanced Bionics, LLC

Cochlear implant implantable magnet

• Primary Device ID: 00840094456198
• NIH Device Record Key: a0ba66b6-d6d4-4559-a0d3-9bb9e6459781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HiRes 90K™ Replacement Magnet
• Version Model Number: CI-1412
• Company DUNS: 803906382
• Company Name: Advanced Bionics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094456198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

FDA Product Code

• MCM: Implant, cochlear

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-31
• Device Publish Date: 2025-07-23

Devices Manufactured by Advanced Bionics, LLC

• 00840094415669 - M Carrying Case: 2025-08-19
• 00840094456198 - HiRes 90K™ Replacement Magnet: 2025-07-311
• 00840094456198 - HiRes 90K™ Replacement Magnet: 2025-07-31 1
• 00840094481640 - HiRes™ Ultra CI HiFocus™ SlimJ Electrode: 2024-08-26
• 00840094483156 - HiRes™ Ultra CI HiFocus™ MS Electrode: 2024-08-26
• 00840094455962 - HiRes™ Ultra CI HiFocus™ MS Electrode: 2024-08-19
• 00840094455993 - HiRes™ Ultra 3D CI HiFocus™ MS Electrode: 2024-08-19
• 00840094456020 - HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode: 2024-08-19
• 00840094448247 - Auria™ PowerCel™ Slim: 2024-07-23 Silver Metallic